Recall archive / FDA device enforcement

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: ... — FDA record Z-2419-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 27, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
Reason: CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air Detector, 4. Single Bubble Air Detection, 5. Error Codes Not Displayed at Power Up, 6. Audible Alarm, 7. Low Sensitivity Air in Line Detection Threshold, 8. PharmGuard Server Password. Smiths Medical corrected many of the issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent CADD software (v4.3 - 2023) installed on your pumps.
Classification: Class I
Recalling firm: Smiths Medical ASD Inc.
Quantity: 9284 units
Agency-reported status: Ongoing
Source record identifier: Z-2419-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	REF List Number: 21-2101-0200-02; UDI/DI 30610586035337, Serial Numbers: 1006964, 1006966, 1006969, 1008404, 1008405, 1009451, 1010631, 1014398, 1010689, 1010420, 1010442, 1010443, 1010444, 1010445, 1005368, 1005365, 1006283, 1006298, 1008409, 1009427, 1009428, 1009429, 1009431, 1009433, 1010419, 1011448, 1011450, 1011451, 1011452, 1006964, 1006966, 1008404, 1009451, 1011447, 1011449, 1010432, 1009715; REF List Number: 21-2101-00; UDI/DI 10610586032950, Serial Numbers: 1002001, 1002001, 1002006, 1002009, 1002010, 1002014, 1002016, 1002017, 1002018, 1002023, 1002025, 1002026, 1002028, 1002031, 1002033, 1002034, 1002036, 1002037, 1002039, 1002040, 1002041, 1002042, 1002043, 1002045, 1002051, 1002053, 1002054, 1002055, 1002058, 1002059, 1002060, 1002063, 1002064, 1002065, 1002067, 1002068, 1002070, 1002072, 1002074, 1002077, 1002078, 1002081, 1002082, 1002085, 1002086, 1002088, 1002090, 1002094, 1002095, 1002097, 1002101, 1002103, 1002105, 1002106, 1002107, 1002108, 1002109, 1002110, 1002111, 1002113, 1002114, 1002117, 1002118, 1002119, 1002120, 1002121, 1002122, 1002123, 1002125, 1002259, 1002392, 1002406, 1002407, 1002408, 1002409, 1002410, 1002412, 1002414, 1002415, 1002416, 1002417, 1002418, 1002419, 1002420, 1002421, 1002422, 1002423, 1002424, 1002425, 1002426, 1002427, 1002428, 1002432, 1002433, 1002434, 1002436, 1002437, 1002439, 1002440, 1002442, 1002443, 1002444, 1002445, 1002448, 1002449, 1002452, 1002453, 1002497, 1002547, 1002575, 1002581, 1002583, 1002588, 1002593, 1002607, 1002620, 1002627, 1002658, 1002662, 1002753, 1002766, 1002781, 1002800, 1002815, 1002821, 1002824, 1002828, 1002831, 1002832, 1002833, 1002836, 1002838, 1002842, 1002845, 1002848, 1002868, 1002877, 1002880, 1002899, 1002952, 1002984, 1002987, 1003161, 1003170, 1003172, 1003183, 1003192, 1003632, 1003885, 1004654, 1005061, 10012441, 1005352, 1005445, 1006255, 1006625, 1006626, 1006627, 1006628, 1006629, 1006630, 1006631, 1006634, 1006635, 1006636, 1006709, 1007033, 1007509, 1007546, 1007593, 1007608, 1007627, 1007842, 1009082, 1011821, 1010639, 1010640, 1010642, 1010645, 1010648, 1010649, 1010650, 1010655, 1010658, 1010660, 1010662, 1010717, 1010805, 1011134, 1011140, 1011143, 1011290, 1011486, 1011782, 1011816, 1011818, 1011823, 1012047, 1012080, 1012244, 1002003, 1002007, 1002024, 1002413, 1002455, 1002553, 1002817, 1006633, 1002013, 1002050, 1002052, 1002056, 1002066, 1002022, 1010863, 1009085, 1002411, 1002080; REF List Number: 21-2101-0100-50; UDI/DI 10610586035548, Serial Numbers: 1011545, 1009720, 1010437, 1010634, 1010635, 1010666, 1010667, 1010668, 1010669, 1010670, 1010671, 1010672, 1010673, 1010674, 1010675, 1010676, 1010679, 1010682, 1010684, 1010685, 1010686, 1010687, 1010688, 1011520, 1011522, 1011528, 1011537, 1011538, 1011523, 1011542, 1011549, 1011550, 1011535, 1011556, 1011995, 1011996, 1010677, 1010680, 1010681, 1012342, 1012343, 1012344, 1012340, 1012341, 1011994, 1011515, 1011516, 1011517, 1011518, 1011519, 1011521, 1011524, 1011525, 1011526, 1011527, 1011529, 1011531, 1011533, 1011534, 1011536, 1011539, 1011540, 1011541, 1011543, 1011544, 1011546, 1011547, 1011548, 1011551, 1011552, 1011553, 1011554, 1011555, 1011557, 1011558, 1011559, 1011560, 1011561, 1011562, 1011563, 1011532, 1011564; REF List Number: 21-2101-0200-03; UDI/DI 30610586035344, Serial Numbers: 1008473, 1009307, 1009483, 1009484, 1009485, 1009486, 1009487, 1009488, 1009489, 1009490, 1009507, 1009508, 1009514, 1009520, 1009522, 1009524, 1009526, 1009527, 1009792, 1009795, 1009797, 1009800, 1009801, 1009802, 1009803, 1009804, 1009806, 1009833, 1009834, 1009835, 1009836, 1009837, 1009838, 1009839, 1009840, 1009841, 1010370, 1010372, 1010374, 1010375, 1010381, 1010386, 1010390, 1010411, 1010423, 1010427, 1010429, 1010467, 1010474, 1010514, 1010573, 1010574, 1010580, 1010581, 1010582, 1010583, 1010585, 1010586, 1010587, 1010589, 1010590, 1010591, 1010592, 1010593, 1010594, 1010595, 1010596, 1010597, 1010599, 1010600, 1010601, 1010602, 1010603, 1010605, 1010606, 1010611, 1010613, 1010614, 1010628, 1010630, 1010384, 1010376, 1010377, 1010378, 1010383, 1010380, 1009796, 1010382, 1010387, 1010588, 1008468, 1010541, 1010584, 1008467, 1009832, 1010385, 1009493, 1009494, 1009495, 1009497, 1009499, 1009500, 1009501, 1009503, 1009504, 1009502, 1009452, 1009453, 1009454, 1009455, 1009456, 1009457, 1009458, 1009459, 1009460, 1009462, 1009463, 1009464, 1009465, 1009466, 1009467, 1009468, 1009470, 1009471, 1009472, 1009473, 1009474, 1009475, 1009476, 1009478, 1009479, 1009480, 1009498, 1009515, 1009516, 1009518, 1009519, 1009521, 1010607, 1010608, 1010609, 1010610, 1009523, 1010371, 1009827, 1009828, 1009829, 1009830, 1009831, 1009509, 1009510, 1009511, 1009512, 1009513, 1010388, 1010389, 1010405, 1009807, 1009808, 1009809, 1009810, 1009811, 1009812, 1009813, 1009814, 1009815, 1009816, 1009817, 1009818, 1009819, 1009820, 1009821, 1009822, 1009823, 1009824, 1009825, 1009826, 1010379, 1009492, 1009491, 1009505, 1009506, 1009525, 1009798, 1009528, 1009461; REF List Number: 21-2101-0200-06; UDI/DI 10610586035357, Serial Numbers: 1003934, 1006600, 1006601, 1006602, 1009591, 1009592, 1009593, 1009594, 1009595, 1009596, 1009597, 1009598, 1009599, 1009600, 1009601, 1009602, 1009603, 1009604, 1009605, 1009606, 1009607, 1009608, 1009609, 1009610, 1009611, 1009612, 1009613, 1009614, 1009615, 1009616, 1009617, 1009618, 1009619, 1009620, 1009621, 1009622, 1009623, 1009624, 1009625, 1009626, 1009627, 1009628, 1009629, 1009630, 1009631, 1009632, 1009633, 1009634, 1009635, 1009636, 1009637, 1009638, 1009639, 1009640, 1009641, 1009642, 1009643, 1009644, 1009645, 1009646, 1009647, 1009648, 1009649, 1009650, 1009651, 1009305, 1009588, 1009589, 1009590; REF List Number: 21-2101-0200-07; UDI/DI 30610586035368, Serial Numbers: 1010450, 1010451, 1010452, 1010453, 1010454, 1010455, 1010456, 1010457, 1010458, 1010459, 1010460, 1010462, 1010463, 1010464, 1010616, 1010617, 1010618, 1010619, 1010620, 1010621, 1010622, 1010623, 1010624, 1010625, 1010626, 1025383, 1010447, 1010449, 1010448, 1010446; REF List Number: 21-2101-0200-12; UDI/DI 10610586035395, Serial Numbers: 1009584, 1009585, 1009586, 1009587, 1009582, 1009583, 1009581, 1009444; REF List Number: 21-2101-0200-14; UDI/DI 10610586035401, Serial Numbers: 1009543, 1009545, 1009547, 1009548, 1009552, 1009549, 1009550, 1009551, 1009443, 1009544, 1009546, 1009553; REF List Number: 21-2101-0200-17; UDI/DI 10610586035418, Serial Numbers: 1009532, 1009529, 1009542, 1009535, 1009536, 1009537, 1009538, 1009539, 1009540, 1009541; REF List Number: 21-2101-0200-232; UDI/DI 10610586035425, Serial Numbers: 1001841 REF 21-21-1-0200-236; UDI/DI 10610586035449, Serial Numbers: 1001870; REF List Number: 21-2101-0200-237; UDI/DI 10610586035456, Serial Numbers: 1001844; REF List Number: 21-2101-0200-238; UDI/DI 10610586035463, Serial Numbers: 1001893; REF List Number: 21-2101-0200-242; UDI/DI 10610586035487, Serial Numbers: 1001838; REF List Number: 21-2101-0200-244; UDI/DI 10610586035494, Serial Numbers: 1001888 REF List Number: 21-2101-249, 21-2111-0402-02, 21-2120-0103-02, 21-2120-0105-15L, 21-2111-0402-09JP, 21-2111-0400-78, 21-2120-0105-06L, 21-2120-0105-50, 21-2120-0105-08L, 21-2120-0103-06, 21-2120-0103-06L, 21-2120-0105-02L, 21-2120-0105-07L, 22-4095-0203-51, UDI/DI None, Serial Numbers: 000688, 003836, 003839, 1000681, 1001701, 1001702, 1001703, 1001704, 1001705, 1001706, 1001707, 1001708, 1001709, 1001710, 1001711, 1001712, 1001713, 1001714, 1001715, 1001716, 1001717, 1001718, 1001720, 1001721, 1001722, 1001724, 1001725, 1001726, 1001727, 1001728, 1001729, 1001730, 1001732, 1001733, 1001735, 1001736, 1001737, 1001738, 1001739, 1001740, 1001742, 1001743, 1001744, 1001746, 1001748, 1001750, 1001752, 1001753, 1001754, 1001755, 1001756, 1001757, 1001758, 1001759, 1001761, 1001762, 1001763, 1001765, 1001766, 1001770, 1001771, 1001772, 1001773, 1001774, 1001775, 1001777, 1001778, 1001779, 1001780, 1001781, 1001782, 1001784, 1001785, 1001786, 1001787, 1001788, 1001789, 1001790, 1001895, 1001901, 1001902, 1001906, 1001909, 1001911, 1001912, 1001913, 1001914, 1001915, 1001916, 1001917, 1001918, 1001919, 1001921, 1001922, 1001924, 1001925, 1001926, 1001927, 1001928, 1001929, 1001930, 1001931, 1001932, 1001933, 1001934, 1001935, 1001936, 1001937, 1001938, 1001939, 1001940, 1001941, 1001942, 1001943, 1001944, 1001945, 1001946, 1001947, 1001948, 1001949, 1001950, 1001951, 1001952, 1001953, 1002002, 1002005, 1002008, 1002035, 1002038, 1002044, 1002047, 1002048, 1002073, 1002093, 1002100, 1002431, 1002435, 1002441, 1002451, 1002454, 1002570, 1002571, 1002600, 1002604, 1002614, 1002623, 1002705, 1002812, 1002816, 1002818, 1002822, 1002835, 1003010, 1003110, 1003119, 1003128, 1003153, 1003156, 1003459, 1003524, 1003595, 1003638, 1003644, 1003677, 1003682, 1003760, 1003770, 1003794, 1003810, 1003822, 1003825, 1003826, 1003828, 1003839, 1003851, 1003857, 1003863, 1003903, 1004023, 1004068, 1004069, 1004070, 1004071, 1004072, 1004650, 1005607, 1005908, 1005909, 1005910, 1005911, 1005913, 1005914, 1005915, 1005916, 1005917, 1005921, 1005923, 1005925, 1005926, 1005927, 1006153, 1006167, 1006391, 1006632, 1006896, 1006897, 1006898, 1006899, 1007029, 1007101, 1007156, 1007217, 1007506, 1007603, 1007745, 1007903, 1007974, 1007975, 1008186, 1008469, 1008474, 1008487, 1009142, 1009170, 1009175, 1009181, 1009183, 1009430, 1010417, 1010636, 1010643, 1010647, 1010653, 1010663, 1010665, 1010932, 1011034, 1011289, 1011814, 1011815, 1011817, 1011819, 1011822, 1011852, 1012859, 1012875, 1012886, 1012887, 1012897, 1012898, 1012904, 1012910, 1013044, 1013116, 1013119, 1013129, 1013130, 1013134, 1013135, 1013136, 1013137, 1013138, 1013139, 1013141, 1013142, 1013143, 1013152, 1013161, 1013164, 1013793, 1013833, 1013905, 1014047, 1014058, 1014059, 1014077, 1014093, 1014164, 1014168, 1014171, 1014177, 1014181, 1014183, 1014185, 1014223, 1014224, 1014229, 1014231, 1014232, 1014233, 1014236, 1014250, 1014251, 1014585, 1014586, 1014591, 1014600, 1014601, 1014602, 1014603, 1014609, 1014614, 1014616, 1014621, 1016236, 1016237, 1016238, 1016240, 1016243, 1016395, 1019369, 1021955, 1022089, 1022117, 1022358, 1022360, 1022363, 1022709, 1022830, 1022936, 1022965, 1022974, 1023020, 1023021, 1023029, 1023033, 1023049, 1023050, 1023054, 1023059, 1023062, 1023066, 1023070, 1024086, 1001783, 1003668, 1003670, 1003671, 1003674, 1003680, 1003681, 1003687, 1001767, 1001745, 1001769, 1003883, 1001747, 1001751, 1001760, 1001741, 1001719, 1001838A, 1001841A, 1001844A, 1001870A, 1001888A, 1001893A, 1003836A, 1008476A; REF List Number: 21-2101-51; UDI/DI 10610586031854, Serial Numbers: 691953, 691954, 694918, 694919, 694964, 1001814, 1001816, 1001817, 1001818, 1001819, 1001820, 1001821, 1001822, 1001823, 1001824, 1001825, 1001826, 1001827, 1001828, 1001829, 1001830, 1001831, 1001832, 1001833, 1001834, 1001835, 1001836, 1001837, 1001839, 1001840, 1001842, 1001843, 1001845, 1001846, 1001847, 1001848, 1001849, 1001850, 1001851, 1001852, 1001853, 1001854, 1001855, 1001856, 1001857, 1001858, 1001859, 1001860, 1001861, 1001862, 1001863, 1001864, 1001865, 1001866, 1001REF List867, 1001868, 1001869, 1001871, 1001872, 1001873, 1001874, 1001875, 1001876, 1001877, 1001878, 1001879, 1001880, 1001881, 1001882, 1001883, 1001884, 1001885, 1001886, 1001889, 1001890, 1001891, 1001892, 1002126, 1002127, 1002129, 1002130, 1002137, 1002138, 1002139, 1002142, 1002143, 1002144, 1002145, 1002146, 1002147, 1002148, 1002149, 1002150, 1002151, 1002153, 1002154, 1002156, 1002158, 1002160, 1002161, 1002162, 1002163, 1002164, 1002165, 1002167, 1002169, 1002170, 1002171, 1002172, 1002174, 1002175, 1002176, 1002177, 1002179, 1002180, 1002182, 1002183, 1002184, 1002185, 1002188, 1002190, 1002191, 1002192, 1002194, 1002195, 1002196, 1002198, 1002199, 1002200, 1002203, 1002204, 1002207, 1002209, 1002210, 1002211, 1002213, 1002214, 1002216, 1002217, 1002218, 1002219, 1002221, 1002222, 1002225, 1002227, 1002228, 1002230, 1002231, 1002234, 1002235, 1002237, 1002238, 1002239, 1002240, 1002241, 100...

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Details supplied by the agency

Lot, code or applicability

REF List Number: 21-2101-0200-02; UDI/DI 30610586035337, Serial Numbers: 1006964, 1006966, 1006969, 1008404, 1008405, 1009451, 1010631, 1014398, 1010689, 1010420, 1010442, 1010443, 1010444, 1010445, 1005368, 1005365, 1006283, 1006298, 1008409, 1009427, 1009428, 1009429, 1009431, 1009433, 1010419, 1011448, 1011450, 1011451, 1011452, 1006964, 1006966, 1008404, 1009451, 1011447, 1011449, 1010432, 1009715; REF List Number: 21-2101-00; UDI/DI 10610586032950, Serial Numbers: 1002001, 1002001, 1002006, 1002009, 1002010, 1002014, 1002016, 1002017, 1002018, 1002023, 1002025, 1002026, 1002028, 1002031, 1002033, 1002034, 1002036, 1002037, 1002039, 1002040, 1002041, 1002042, 1002043, 1002045, 1002051, 1002053, 1002054, 1002055, 1002058, 1002059, 1002060, 1002063, 1002064, 1002065, 1002067, 1002068, 1002070, 1002072, 1002074, 1002077, 1002078, 1002081, 1002082, 1002085, 1002086, 1002088, 1002090, 1002094, 1002095, 1002097, 1002101, 1002103, 1002105, 1002106, 1002107, 1002108, 1002109, 1002110, 1002111, 1002113, 1002114, 1002117, 1002118, 1002119, 1002120, 1002121, 1002122, 1002123, 1002125, 1002259, 1002392, 1002406, 1002407, 1002408, 1002409, 1002410, 1002412, 1002414, 1002415, 1002416, 1002417, 1002418, 1002419, 1002420, 1002421, 1002422, 1002423, 1002424, 1002425, 1002426, 1002427, 1002428, 1002432, 1002433, 1002434, 1002436, 1002437, 1002439, 1002440, 1002442, 1002443, 1002444, 1002445, 1002448, 1002449, 1002452, 1002453, 1002497, 1002547, 1002575, 1002581, 1002583, 1002588, 1002593, 1002607, 1002620, 1002627, 1002658, 1002662, 1002753, 1002766, 1002781, 1002800, 1002815, 1002821, 1002824, 1002828, 1002831, 1002832, 1002833, 1002836, 1002838, 1002842, 1002845, 1002848, 1002868, 1002877, 1002880, 1002899, 1002952, 1002984, 1002987, 1003161, 1003170, 1003172, 1003183, 1003192, 1003632, 1003885, 1004654, 1005061, 10012441, 1005352, 1005445, 1006255, 1006625, 1006626, 1006627, 1006628, 1006629, 1006630, 1006631, 1006634, 1006635, 1006636, 1006709, 1007033, 1007509, 1007546, 1007593, 1007608, 1007627, 1007842, 1009082, 1011821, 1010639, 1010640, 1010642, 1010645, 1010648, 1010649, 1010650, 1010655, 1010658, 1010660, 1010662, 1010717, 1010805, 1011134, 1011140, 1011143, 1011290, 1011486, 1011782, 1011816, 1011818, 1011823, 1012047, 1012080, 1012244, 1002003, 1002007, 1002024, 1002413, 1002455, 1002553, 1002817, 1006633, 1002013, 1002050, 1002052, 1002056, 1002066, 1002022, 1010863, 1009085, 1002411, 1002080; REF List Number: 21-2101-0100-50; UDI/DI 10610586035548, Serial Numbers: 1011545, 1009720, 1010437, 1010634, 1010635, 1010666, 1010667, 1010668, 1010669, 1010670, 1010671, 1010672, 1010673, 1010674, 1010675, 1010676, 1010679, 1010682, 1010684, 1010685, 1010686, 1010687, 1010688, 1011520, 1011522, 1011528, 1011537, 1011538, 1011523, 1011542, 1011549, 1011550, 1011535, 1011556, 1011995, 1011996, 1010677, 1010680, 1010681, 1012342, 1012343, 1012344, 1012340, 1012341, 1011994, 1011515, 1011516, 1011517, 1011518, 1011519, 1011521, 1011524, 1011525, 1011526, 1011527, 1011529, 1011531, 1011533, 1011534, 1011536, 1011539, 1011540, 1011541, 1011543, 1011544, 1011546, 1011547, 1011548, 1011551, 1011552, 1011553, 1011554, 1011555, 1011557, 1011558, 1011559, 1011560, 1011561, 1011562, 1011563, 1011532, 1011564; REF List Number: 21-2101-0200-03; UDI/DI 30610586035344, Serial Numbers: 1008473, 1009307, 1009483, 1009484, 1009485, 1009486, 1009487, 1009488, 1009489, 1009490, 1009507, 1009508, 1009514, 1009520, 1009522, 1009524, 1009526, 1009527, 1009792, 1009795, 1009797, 1009800, 1009801, 1009802, 1009803, 1009804, 1009806, 1009833, 1009834, 1009835, 1009836, 1009837, 1009838, 1009839, 1009840, 1009841, 1010370, 1010372, 1010374, 1010375, 1010381, 1010386, 1010390, 1010411, 1010423, 1010427, 1010429, 1010467, 1010474, 1010514, 1010573, 1010574, 1010580, 1010581, 1010582, 1010583, 1010585, 1010586, 1010587, 1010589, 1010590, 1010591, 1010592, 1010593, 1010594, 1010595, 1010596, 1010597, 1010599, 1010600, 1010601, 1010602, 1010603, 1010605, 1010606, 1010611, 1010613, 1010614, 1010628, 1010630, 1010384, 1010376, 1010377, 1010378, 1010383, 1010380, 1009796, 1010382, 1010387, 1010588, 1008468, 1010541, 1010584, 1008467, 1009832, 1010385, 1009493, 1009494, 1009495, 1009497, 1009499, 1009500, 1009501, 1009503, 1009504, 1009502, 1009452, 1009453, 1009454, 1009455, 1009456, 1009457, 1009458, 1009459, 1009460, 1009462, 1009463, 1009464, 1009465, 1009466, 1009467, 1009468, 1009470, 1009471, 1009472, 1009473, 1009474, 1009475, 1009476, 1009478, 1009479, 1009480, 1009498, 1009515, 1009516, 1009518, 1009519, 1009521, 1010607, 1010608, 1010609, 1010610, 1009523, 1010371, 1009827, 1009828, 1009829, 1009830, 1009831, 1009509, 1009510, 1009511, 1009512, 1009513, 1010388, 1010389, 1010405, 1009807, 1009808, 1009809, 1009810, 1009811, 1009812, 1009813, 1009814, 1009815, 1009816, 1009817, 1009818, 1009819, 1009820, 1009821, 1009822, 1009823, 1009824, 1009825, 1009826, 1010379, 1009492, 1009491, 1009505, 1009506, 1009525, 1009798, 1009528, 1009461; REF List Number: 21-2101-0200-06; UDI/DI 10610586035357, Serial Numbers: 1003934, 1006600, 1006601, 1006602, 1009591, 1009592, 1009593, 1009594, 1009595, 1009596, 1009597, 1009598, 1009599, 1009600, 1009601, 1009602, 1009603, 1009604, 1009605, 1009606, 1009607, 1009608, 1009609, 1009610, 1009611, 1009612, 1009613, 1009614, 1009615, 1009616, 1009617, 1009618, 1009619, 1009620, 1009621, 1009622, 1009623, 1009624, 1009625, 1009626, 1009627, 1009628, 1009629, 1009630, 1009631, 1009632, 1009633, 1009634, 1009635, 1009636, 1009637, 1009638, 1009639, 1009640, 1009641, 1009642, 1009643, 1009644, 1009645, 1009646, 1009647, 1009648, 1009649, 1009650, 1009651, 1009305, 1009588, 1009589, 1009590; REF List Number: 21-2101-0200-07; UDI/DI 30610586035368, Serial Numbers: 1010450, 1010451, 1010452, 1010453, 1010454, 1010455, 1010456, 1010457, 1010458, 1010459, 1010460, 1010462, 1010463, 1010464, 1010616, 1010617, 1010618, 1010619, 1010620, 1010621, 1010622, 1010623, 1010624, 1010625, 1010626, 1025383, 1010447, 1010449, 1010448, 1010446; REF List Number: 21-2101-0200-12; UDI/DI 10610586035395, Serial Numbers: 1009584, 1009585, 1009586, 1009587, 1009582, 1009583, 1009581, 1009444; REF List Number: 21-2101-0200-14; UDI/DI 10610586035401, Serial Numbers: 1009543, 1009545, 1009547, 1009548, 1009552, 1009549, 1009550, 1009551, 1009443, 1009544, 1009546, 1009553; REF List Number: 21-2101-0200-17; UDI/DI 10610586035418, Serial Numbers: 1009532, 1009529, 1009542, 1009535, 1009536, 1009537, 1009538, 1009539, 1009540, 1009541; REF List Number: 21-2101-0200-232; UDI/DI 10610586035425, Serial Numbers: 1001841 REF 21-21-1-0200-236; UDI/DI 10610586035449, Serial Numbers: 1001870; REF List Number: 21-2101-0200-237; UDI/DI 10610586035456, Serial Numbers: 1001844; REF List Number: 21-2101-0200-238; UDI/DI 10610586035463, Serial Numbers: 1001893; REF List Number: 21-2101-0200-242; UDI/DI 10610586035487, Serial Numbers: 1001838; REF List Number: 21-2101-0200-244; UDI/DI 10610586035494, Serial Numbers: 1001888 REF List Number: 21-2101-249, 21-2111-0402-02, 21-2120-0103-02, 21-2120-0105-15L, 21-2111-0402-09JP, 21-2111-0400-78, 21-2120-0105-06L, 21-2120-0105-50, 21-2120-0105-08L, 21-2120-0103-06, 21-2120-0103-06L, 21-2120-0105-02L, 21-2120-0105-07L, 22-4095-0203-51, UDI/DI None, Serial Numbers: 000688, 003836, 003839, 1000681, 1001701, 1001702, 1001703, 1001704, 1001705, 1001706, 1001707, 1001708, 1001709, 1001710, 1001711, 1001712, 1001713, 1001714, 1001715, 1001716, 1001717, 1001718, 1001720, 1001721, 1001722, 1001724, 1001725, 1001726, 1001727, 1001728, 1001729, 1001730, 1001732, 1001733, 1001735, 1001736, 1001737, 1001738, 1001739, 1001740, 1001742, 1001743, 1001744, 1001746, 1001748, 1001750, 1001752, 1001753, 1001754, 1001755, 1001756, 1001757, 1001758, 1001759, 1001761, 1001762, 1001763, 1001765, 1001766, 1001770, 1001771, 1001772, 1001773, 1001774, 1001775, 1001777, 1001778, 1001779, 1001780, 1001781, 1001782, 1001784, 1001785, 1001786, 1001787, 1001788, 1001789, 1001790, 1001895, 1001901, 1001902, 1001906, 1001909, 1001911, 1001912, 1001913, 1001914, 1001915, 1001916, 1001917, 1001918, 1001919, 1001921, 1001922, 1001924, 1001925, 1001926, 1001927, 1001928, 1001929, 1001930, 1001931, 1001932, 1001933, 1001934, 1001935, 1001936, 1001937, 1001938, 1001939, 1001940, 1001941, 1001942, 1001943, 1001944, 1001945, 1001946, 1001947, 1001948, 1001949, 1001950, 1001951, 1001952, 1001953, 1002002, 1002005, 1002008, 1002035, 1002038, 1002044, 1002047, 1002048, 1002073, 1002093, 1002100, 1002431, 1002435, 1002441, 1002451, 1002454, 1002570, 1002571, 1002600, 1002604, 1002614, 1002623, 1002705, 1002812, 1002816, 1002818, 1002822, 1002835, 1003010, 1003110, 1003119, 1003128, 1003153, 1003156, 1003459, 1003524, 1003595, 1003638, 1003644, 1003677, 1003682, 1003760, 1003770, 1003794, 1003810, 1003822, 1003825, 1003826, 1003828, 1003839, 1003851, 1003857, 1003863, 1003903, 1004023, 1004068, 1004069, 1004070, 1004071, 1004072, 1004650, 1005607, 1005908, 1005909, 1005910, 1005911, 1005913, 1005914, 1005915, 1005916, 1005917, 1005921, 1005923, 1005925, 1005926, 1005927, 1006153, 1006167, 1006391, 1006632, 1006896, 1006897, 1006898, 1006899, 1007029, 1007101, 1007156, 1007217, 1007506, 1007603, 1007745, 1007903, 1007974, 1007975, 1008186, 1008469, 1008474, 1008487, 1009142, 1009170, 1009175, 1009181, 1009183, 1009430, 1010417, 1010636, 1010643, 1010647, 1010653, 1010663, 1010665, 1010932, 1011034, 1011289, 1011814, 1011815, 1011817, 1011819, 1011822, 1011852, 1012859, 1012875, 1012886, 1012887, 1012897, 1012898, 1012904, 1012910, 1013044, 1013116, 1013119, 1013129, 1013130, 1013134, 1013135, 1013136, 1013137, 1013138, 1013139, 1013141, 1013142, 1013143, 1013152, 1013161, 1013164, 1013793, 1013833, 1013905, 1014047, 1014058, 1014059, 1014077, 1014093, 1014164, 1014168, 1014171, 1014177, 1014181, 1014183, 1014185, 1014223, 1014224, 1014229, 1014231, 1014232, 1014233, 1014236, 1014250, 1014251, 1014585, 1014586, 1014591, 1014600, 1014601, 1014602, 1014603, 1014609, 1014614, 1014616, 1014621, 1016236, 1016237, 1016238, 1016240, 1016243, 1016395, 1019369, 1021955, 1022089, 1022117, 1022358, 1022360, 1022363, 1022709, 1022830, 1022936, 1022965, 1022974, 1023020, 1023021, 1023029, 1023033, 1023049, 1023050, 1023054, 1023059, 1023062, 1023066, 1023070, 1024086, 1001783, 1003668, 1003670, 1003671, 1003674, 1003680, 1003681, 1003687, 1001767, 1001745, 1001769, 1003883, 1001747, 1001751, 1001760, 1001741, 1001719, 1001838A, 1001841A, 1001844A, 1001870A, 1001888A, 1001893A, 1003836A, 1008476A; REF List Number: 21-2101-51; UDI/DI 10610586031854, Serial Numbers: 691953, 691954, 694918, 694919, 694964, 1001814, 1001816, 1001817, 1001818, 1001819, 1001820, 1001821, 1001822, 1001823, 1001824, 1001825, 1001826, 1001827, 1001828, 1001829, 1001830, 1001831, 1001832, 1001833, 1001834, 1001835, 1001836, 1001837, 1001839, 1001840, 1001842, 1001843, 1001845, 1001846, 1001847, 1001848, 1001849, 1001850, 1001851, 1001852, 1001853, 1001854, 1001855, 1001856, 1001857, 1001858, 1001859, 1001860, 1001861, 1001862, 1001863, 1001864, 1001865, 1001866, 1001REF List867, 1001868, 1001869, 1001871, 1001872, 1001873, 1001874, 1001875, 1001876, 1001877, 1001878, 1001879, 1001880, 1001881, 1001882, 1001883, 1001884, 1001885, 1001886, 1001889, 1001890, 1001891, 1001892, 1002126, 1002127, 1002129, 1002130, 1002137, 1002138, 1002139, 1002142, 1002143, 1002144, 1002145, 1002146, 1002147, 1002148, 1002149, 1002150, 1002151, 1002153, 1002154, 1002156, 1002158, 1002160, 1002161, 1002162, 1002163, 1002164, 1002165, 1002167, 1002169, 1002170, 1002171, 1002172, 1002174, 1002175, 1002176, 1002177, 1002179, 1002180, 1002182, 1002183, 1002184, 1002185, 1002188, 1002190, 1002191, 1002192, 1002194, 1002195, 1002196, 1002198, 1002199, 1002200, 1002203, 1002204, 1002207, 1002209, 1002210, 1002211, 1002213, 1002214, 1002216, 1002217, 1002218, 1002219, 1002221, 1002222, 1002225, 1002227, 1002228, 1002230, 1002231, 1002234, 1002235, 1002237, 1002238, 1002239, 1002240, 1002241, 100...

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Report date: Aug 14, 2024
Recall initiation date: Feb 27, 2024
Center classification date: Aug 2, 2024

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